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Abbott Electrophysiology recalls FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060
Recalled September 9, 2015 · FDA recall Z-2478-2015 · Abbott Electrophysiology
Hazard
The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. The manufacturing date was accidentally used (copied) for the expiration date. · FDA Class III
Units
86 units
Sold at
US Distribution in states of: KY, IN, MO, NY, OH, TX, LA, IL, PA, NJ, WA, VA, FL, GA, CT, CA, AZ, CO, and TN.
Description
The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. The manufacturing date was accidentally used (copied) for the expiration date.
Product
FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
Manufacturer(s)
Abbott Electrophysiology
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →